Using tacrolimus ointment to treat rare vascular tumors in children
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma：a Randomized Controlled Study
This study is testing if a special ointment called tacrolimus can help treat rare skin tumors in children and how safe it is to use.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT04056962 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of different concentrations of topical tacrolimus for treating superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA) in children. These rare vascular tumors typically appear in infancy or early childhood, and there are currently no established treatment protocols. The study aims to determine how effective tacrolimus ointment is in managing these conditions and to assess any associated safety concerns.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with superficial Kaposiform hemangioendothelioma or tufted angioma.
Not a fit: Patients with hypersensitivity to tacrolimus or those with mucosal forms of KHE and TA may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing superficial KHE and TA in children.
How similar studies have performed: While there is limited data on the use of tacrolimus for these specific conditions, similar approaches have shown promise in treating other vascular tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA) Exclusion Criteria: * Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
Where this trial is running
Chengdu, Sichuan
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Yi Ji — West China Hospital
- Study coordinator: Yi Ji, PHD, MD
- Email: jijiyuanyuan@163.com
- Phone: +86 13980544622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.